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临床试验/NCT05182827
NCT05182827已完成不适用

Affective Touch, Hedonia and Suicidal Behavior

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Pleasantness of the touch

研究概览

简要总结

Several elements suggest that suicidal vulnerability may be associated with an alteration in the perception of affective touch. On the one hand, anhedonia, characterized by a decrease in the pleasure felt, is strongly associated with suicidal ideation, independently of depression. However, the ability to feel pleasure is essential in the perception of affective touch. On the other hand, suicidal behaviors are associated with interpersonal difficulties, of which communication is an integral part, and communication is partly through touch.

The investigators therefore wish to explore the perception of affective touch in suicidal behavior by using an affective tactile stimulation in 72 subjects with and without a history of suicide attempts (SA).

详细描述

This study aims to compare the perceived hedonic nature of affective touch in euthymic subjects with a history of SA and euthymic subjects without a history of SA.

The investigators also aim to :

  • compare the perceived hedonic nature of non-affective touch in this population;
  • compare the perceived intensity of affective touch;
  • compare the perceived intensity of non-affective touch;
  • study the association between decision making performance and perceived pleasantness of affective vs. non-affective touch;
  • study the association between plasma beta-endorphin levels and the perceived pleasantness of affective vs. non-affective touch;
  • study the effect of the tactile stimulation on the expression of opioidergic genes, by comparing the mRNA levels of 6 genes coding for opioidergic receptors and peptides before and after tactile stimulation;
  • investigate the association between tactile stimulation-related opioidergic gene expression variation and the perception of the pleasantness of affective versus non-affective touch.

To do so, 72 euthymic women will be included and divided in two groups: 1) Euthymic patients with a lifetime history of major depressive episode and a history of suicidal behavior; 2) Euthymic patients with a lifetime history of a major depressive episode and no history of suicidal behavior.

Participants will be subjected to tactile stimulation (affective and non-affective), following a clinical and neurospychological assessment. During the experimental touch, participants will be asked to evaluate the pleasantness of the touch and its intensity. In addition, blood samples will be taken before and after the stimulation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being a woman
  • Aged between 18 and 65
  • Past major depressive episode according to the DSM-5 criteria
  • Currently euthymic (Montgomery-Asberg Depression rating Scale (MADRS) < 12 and Young Mania Rating Scale (YMRS) < 6)
  • Minimal psychotropic medication (as determined by the clinician)
  • Able to understand experimental procedures
  • Able to speak, read and understand French
  • Having given written informed consent
  • For suicide attempters only: Lifetime history of suicide attempt
  • For affective controls only: No lifetime history of suicide attempt

排除标准

  • Lifetime diagnosis of schizoaffective disorder, schizophrenia or autism spectrum disorder
  • Severe alcohol or substance use disorder in the past 6 months
  • Current anorexia nervosa
  • Diagnosis of mental retardation or severe medical comorbidity that is unstable or could interfere with measures (HIV, diabetes, cancer, chronic inflammatory disease, neurological disorder, sensory or cognitive disability)
  • Injury, scar, irritation/dermatological lesion or tattoo on the left forearm
  • Pregnancy or breastfeeding
  • Being in exclusion period for another study
  • Not being affiliated to the French National Social Security System
  • Being deprived of freedom (by judicial or administrative decision)
  • Being protected by law (guardianship or curatorship)
  • Having reached 4500€ annual compensation for participating to clinical trials

结局指标

主要结局

Pleasantness of the touch

时间窗: at inclusion

Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)

次要结局

  • Decision-making performance (Iowa Gambling Test)(at inclusion)
  • Intensity of the touch(at inclusion)
  • Decision-making performance (Ultimatum Game)(at inclusion)
  • β-endorphin levels(at inclusion)
  • Variation in the expression of opioidergic genes(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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